Trial Outcomes & Findings for EL625 in Persistent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT NCT00636155)
NCT ID: NCT00636155
Last Updated: 2012-11-28
Results Overview
Overall Response is the total number of participants with a Complete (CR) or Partial (PR) response. CR requires the absence of lymphadenopathy, hepatomegaly or splenomegaly and constitutional symptoms and a normal CBC; bone marrow must be at least normocellular for age, with less than 30% nucleated cells being lymphocytes with no lymphoid nodules. Partial Response: requires ≥ 50% decrease in one of the following: peripheral blood lymphocyte count, lymphadenopathy, enlargement of liver and/or spleen, or bone marrow involvement by CLL AND at least one hematologic parameter met for 2 months.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
every 3 cycles
Results posted on
2012-11-28
Participant Flow
All patients were enrolled from Duke University Medical Center.
Participant milestones
| Measure |
All Patients
EL625 2.4mg/kg/day as a continuous infusion daily for 4 days combined rituximab 375mg/m2 IV on day 2, fludarabine IV 25mg/m2 over 30 minutes on days 2- 4 and cyclophosphamide IV 250mg/m2 over 1 hour on days 2-4.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
All Patients
EL625 2.4mg/kg/day as a continuous infusion daily for 4 days combined rituximab 375mg/m2 IV on day 2, fludarabine IV 25mg/m2 over 30 minutes on days 2- 4 and cyclophosphamide IV 250mg/m2 over 1 hour on days 2-4.
|
|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Stem cell transplant
|
1
|
|
Overall Study
Physician Decision
|
5
|
Baseline Characteristics
EL625 in Persistent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Baseline characteristics by cohort
| Measure |
All Patients
n=20 Participants
EL625 2.4mg/kg/day as a continuous infusion daily for 4 days combined rituximab 375mg/m2 IV on day 2, fludarabine IV 25mg/m2 over 30 minutes on days 2- 4 and cyclophosphamide IV 250mg/m2 over 1 hour on days 2-4.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: every 3 cyclesPopulation: Patients completing at least 2 cycles of treatment
Overall Response is the total number of participants with a Complete (CR) or Partial (PR) response. CR requires the absence of lymphadenopathy, hepatomegaly or splenomegaly and constitutional symptoms and a normal CBC; bone marrow must be at least normocellular for age, with less than 30% nucleated cells being lymphocytes with no lymphoid nodules. Partial Response: requires ≥ 50% decrease in one of the following: peripheral blood lymphocyte count, lymphadenopathy, enlargement of liver and/or spleen, or bone marrow involvement by CLL AND at least one hematologic parameter met for 2 months.
Outcome measures
| Measure |
All Patients
n=17 Participants
Patients treated with cenersen, fludarabine, cyclphosphamide and rituximab
|
|---|---|
|
Number of Patients With an Overall Response (Complete Response + Partial Response)
|
9 participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: All patients who received treatment
Progression is defined as at least one of the following: 1) ≥ 50% increase in the sum of the products of at least two lymph nodes one two consecutive determinations (at least one node must be ≥ 2 cm); appearance of new palpable lymph nodes, 2) ≥ 50% increase in the size of the liver and/or spleen; appearance of palpable hepatomegaly or splenomegaly, which was not previously present, 3) ≥ 50% increase in the absolute number of circulating lymphocytes to at least 5,000/µl or 4)Transformation to a more aggressive histology.
Outcome measures
| Measure |
All Patients
n=20 Participants
Patients treated with cenersen, fludarabine, cyclphosphamide and rituximab
|
|---|---|
|
Progression Free Survival
|
5.3 months
Interval 4.7 to 14.0
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: All patients who received treatment
Outcome measures
| Measure |
All Patients
n=20 Participants
Patients treated with cenersen, fludarabine, cyclphosphamide and rituximab
|
|---|---|
|
Overall Survival
|
10.6 months
Interval 5.37 to
The upper limit of the confidence interval has not been reached/insufficient number of participants
|
Adverse Events
All Patients
Serious events: 8 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients
n=20 participants at risk
EL625 2.4mg/kg/day as a continuous infusion daily for 4 days combined rituximab 375mg/m2 IV on day 2, fludarabine IV 25mg/m2 over 30 minutes on days 2- 4 and cyclophosphamide IV 250mg/m2 over 1 hour on days 2-4.
|
|---|---|
|
Investigations
Neutrophils / granulocytes (ANC / AGC)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Blood and lymphatic system disorders
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
|
15.0%
3/20 • Number of events 3 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Nervous system disorders
Cognitive disturbance
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Blood and lymphatic system disorders
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Nervous system disorders
Syncope (fainting)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Renal and urinary disorders
Cystitis
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
Other adverse events
| Measure |
All Patients
n=20 participants at risk
EL625 2.4mg/kg/day as a continuous infusion daily for 4 days combined rituximab 375mg/m2 IV on day 2, fludarabine IV 25mg/m2 over 30 minutes on days 2- 4 and cyclophosphamide IV 250mg/m2 over 1 hour on days 2-4.
|
|---|---|
|
Immune system disorders
Allergic reaction / hypersensitivity (including drug fever)
|
10.0%
2/20 • Number of events 3 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Immune system disorders
Allergy / Immunology - Other
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Blood and lymphatic system disorders
Hemoglobin
|
50.0%
10/20 • Number of events 16 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Blood and lymphatic system disorders
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Investigations
Leukocytes (total WBC)
|
40.0%
8/20 • Number of events 13 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Investigations
Neutrophils / granulocytes (ANC / AGC)
|
30.0%
6/20 • Number of events 7 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Investigations
Platelets
|
70.0%
14/20 • Number of events 16 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Cardiac disorders
Palpitations
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial fibrillation
|
5.0%
1/20 • Number of events 3 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Sinus bradycardia
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Sinus tachycardia
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Cardiac disorders
Cardiac General - Other
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Vascular disorders
Hypotension
|
15.0%
3/20 • Number of events 5 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Investigations
INR (International Normalized Ratio of prothrombin time
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
55.0%
11/20 • Number of events 15 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L)
|
15.0%
3/20 • Number of events 3 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Psychiatric disorders
Insomnia
|
25.0%
5/20 • Number of events 7 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
General disorders
Rigors / chills
|
25.0%
5/20 • Number of events 6 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
20.0%
4/20 • Number of events 4 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Investigations
Weight gain
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Investigations
Weight loss
|
15.0%
3/20 • Number of events 3 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Skin and subcutaneous tissue disorders
Dermatology / Skin - Other
|
25.0%
5/20 • Number of events 5 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Skin and subcutaneous tissue disorders
Hair Loss / Alopecia (scalp or body)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus / itching
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial flutter
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Skin and subcutaneous tissue disorders
Rash / desquamation
|
25.0%
5/20 • Number of events 5 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
15.0%
3/20 • Number of events 3 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Vascular disorders
Hot flashes / flushes
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
5/20 • Number of events 5 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Gastrointestinal disorders
Constipation
|
35.0%
7/20 • Number of events 9 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
5/20 • Number of events 5 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Gastrointestinal disorders
Mucositis / stomatitis (clinical exam) - Oral cavity
|
15.0%
3/20 • Number of events 3 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Gastrointestinal disorders
Nausea
|
40.0%
8/20 • Number of events 10 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Gastrointestinal disorders
Obstruction, GI - Ileum
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Nervous system disorders
Taste Alteration (dysgeusia)
|
10.0%
2/20 • Number of events 3 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Vascular disorders
Hemorrhage / Bleeding - Other
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Renal and urinary disorders
Hemorrhage, GU - Kidney
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Skin and subcutaneous tissue disorders
Petechiae / purpura (hemorrhage / bleeding into skin or mucosa)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Hepatobiliary disorders
Liver dysfunction / failure (clinical)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Blood and lymphatic system disorders
Febrile neutropenia (fever of unknown origin w/oclinically or microbiologically documented infe
|
35.0%
7/20 • Number of events 9 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Infections and infestations
Infection - Other
|
15.0%
3/20 • Number of events 4 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Bladder (urin
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils-Lip / perioral
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Rectum
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Urinary tract
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Vascular disorders
Dermal change lymphedema, phlebolymphedema
|
15.0%
3/20 • Number of events 3 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
General disorders
Edema: limb
|
20.0%
4/20 • Number of events 5 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Edema: pulmonary
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
15.0%
3/20 • Number of events 4 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Investigations
Alkaline phosphatase
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Investigations
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
20.0%
4/20 • Number of events 6 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Investigations
Creatinine
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
25.0%
5/20 • Number of events 10 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
15.0%
3/20 • Number of events 3 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Investigations
Metabolic / Laboratory - Other
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
20.0%
4/20 • Number of events 4 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
15.0%
3/20 • Number of events 4 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Metabolism and nutrition disorders
Uric Acid, serum-high (hyperuricemia)
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Musculoskeletal and connective tissue disorders
Joint-function
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body / generalized
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Nervous system disorders
Cognitive disturbance
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Psychiatric disorders
Confusion
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Nervous system disorders
Dizziness
|
20.0%
4/20 • Number of events 7 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Nervous system disorders
Memory Impairment
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Psychiatric disorders
Mood Alteration - Agitation
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Psychiatric disorders
Mood Alteration - Anxiety
|
15.0%
3/20 • Number of events 3 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Psychiatric disorders
Mood Alteration - Depression
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Nervous system disorders
Neuropathy: motor
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Nervous system disorders
Neuropathy: sensory
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Psychiatric disorders
Psychosis (hallucinations / delusions)
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Nervous system disorders
Somnolence / depressed level of consciousness
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Nervous system disorders
Syncope (fainting)
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Eye disorders
Dry Eye Syndrome
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Eye disorders
Vision - blurred vision
|
15.0%
3/20 • Number of events 3 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal - Flank pain
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Gastrointestinal disorders
Pain - Dental / teeth / peridontal
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Nervous system disorders
Pain - Head / headache
|
30.0%
6/20 • Number of events 6 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Blood and lymphatic system disorders
Pain - Lymph node
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Musculoskeletal and connective tissue disorders
Pain - Neck
|
5.0%
1/20 • Number of events 3 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
General disorders
Pain - Other
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary / Upper Respiratory - Sore throat
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
6/20 • Number of events 6 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
35.0%
7/20 • Number of events 11 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
15.0%
3/20 • Number of events 3 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary / Upper Respiratory - Other
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Renal and urinary disorders
Cystitis
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Renal and urinary disorders
Renal Failure
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Renal and urinary disorders
Urinary frequency / urgency
|
25.0%
5/20 • Number of events 6 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of study treatment until 30 days after the last dose.
Other AE section contains all AEs, including SAEs, regardless of attribution to study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place